About Dermavant:
Dermavant Sciences is a clinical-stage biopharmaceutical company focused on developing innovative therapies for inflammatory skin diseases and medical dermatologic conditions.We are passionate and dedicated to realizing the full potential of biomedical research and to developing and commercializing novel first-in-class or best-in-class therapies that improve patients’ lives. The patient is at the heart of everything we do.
Position:
Serves as a key strategic role leading biostatistics, data management and programming tasks for Dermavant Development activities. They will ensure that data collection from the clinical trial development program is properly designed, analyzed and presented to support product development, regulatory submissions and lifecycle management. They will participate in the core team as the Biometrics (biostatistics, data management, and programming) representative. The incumbent will oversee the Biometrics outsourcing activities as well as work very closely with internal and external experts in the relevant fields of activities (clinical development, preclinical, regulatory, etc). They will ensure adequate resourcing (technical, financial, and personnel) to enable Dermavant to meet various timeline targets, including NDA/BLA submissions, FDA advisory panels, 120 day updates, etc. They will work with Dermavant partner(s) to ensure meeting contractual statistical or data obligations, ensuring alignment of any analysis and resource needs with Dermavant priorities and strategies. They will have full accountability and provide direction and statistical oversight for all document and analysis plans, including Standard Operating Procedures (SOPs), registration documents and regulatory interactions; will provide input to clinical development strategies; and will be responsible for technical leadership and successful execution of projects involving statistics, data management, clinical and statistical programming.
Responsibilities:
- Develop and execute optimal statistical methodology for clinical development, and ensure timely completion
- Assist in the creation of strategic objectives for regulatory filings
- Oversee and approve Statistical Analysis Plans (SAPs) and Data Management Plans (DMPs)
- Ensure adequate resourcing of biometrics (Statistics, Data Management and Programming) activities for a program
- Determine best resource allocation (outsourcing vs insourcing) for a program
- Ensure all biometric activities (internal, contract, and CRO) are registration quality, delivered on time and within budget
- Provide leadership in standardizing and optimizing submissions to regulatory authorities and ensure adherence to agency guidelines, Good Clinical Practices, and other regulatory requirements
- Serve as lead project statistician for a program area
- Provide technical direction and oversight of the design, analysis planning, conduct and reporting of clinical studies and data components of CSRs, integrated efficacy and safety summaries
- Establish and implement program standards and SOPs for Statistical input into protocol design, data collection, analysis and summarization of clinical study data
- Directs activities of the functional area Biostatistics with overall responsibility of leading, mentoring, and managing individual contributors
- Direct supervision of Biostatistics, Programming, and Data Management staff
Qualifications:
- Master’s Degree or Ph.D. in Statistics or equivalent
- Minimum 8-10 years of clinical development experience, with an emphasis on statistics, statistical programming, data management, and design and analysis of clinical studies
- Experience with vendor management, including CROs
- Experience with NDA/BLA or MAA Submission
- Experience with Commercial/Global Medical Affairs support post-Approval is preferred
- Direct experience in outsourcing Biometrics operational activities
- Prior supervisory and management experience in both Biostatistics and Programming is required; similar experience in Data Management will be a plus
- Superior organizational and project management skills and ability to multitask
- Strong skills in SAS programming and ability to review programming specifications
- Strong understanding of data management and respective systems
- Have a “hands-on” attitude and be an active problem solver
- Comprehensive knowledge of statistical analysis and regulatory requirements relating to clinical development of pharmaceuticals
- Experience with submissions to Health Authorities and presenting to regulatory agencies
- Excellent analytical, interpersonal, and communication skills
What we look for in our people:
- Highly motivated self-starter with an entrepreneurial spirit and commitment to personal and career development.
- Desire to work in a quickly changing and fast-paced growing business.
- Unrelenting dedication to delivering results and a desire to shape the strategic goals of the business. Willing to roll up your sleeves to get the job done.
- Ability to overcome ambiguity and challenge the status quo
- Manage multiple programs with competing and aggressive time lines, prioritize activities, and work independently.
- Excellent written and oral communication skills; experienced presenter of key messages to broad audiences including Senior Stakeholders